Files & Documents

New: A new version of the study protocol is now availabe. Please see also newsletter No. 10.

Version 2.6 from October 2016 now includes additional preoperative assessment of SpO2 in supine. It is part of a sub-study from Prof. J. Canet (Spain).
Please join this easy-to-implement initiative!

Study protocol, version 2.6 (clean version)

Study protocol, version 2.6 (with tracking changes)

Case Report Form (paper version 1.3)


Other documents (or if you waive joining the substudy)

Study protocol, version 2.5 (clean version)

Study protocol, version 2.5 (with tracking changes)

Case Report Form (paper version 1.2.2)

Approval of study extension (Dresden IRB), by January, 26th 2016

Confirmation of approval by ethics committee

Clinical Study Information for Patients

Informed Consent for Patients

kindly provided by Hamed Elgendy, Makkah, Saudi Arabia

Study Information for Patients

Informed Consent

icf_dr._miao_china_.docx

kindly provided by Ary Serpa Neto, São Paulo, Brazil

Study Protocol version 2.6

Ethics approval

Information for patients and Informed consent

kindly provided by Jing Zhong and Changhong Miao, Shanghai, China

Informed Consent Form

Information for patients

kindly provided by Marc-Joseph Licker and Lukas Kreienbuehl, Geneva, Switzerland

Study Information for Patients + Informed Consent

Summary

All signed amendments

Zustimmung der Ethikkommission

Synopsis PROBESE Studie

Patienteninformation

Erklärung zur Einwilligung

Erklärung zum Datenschutz

kindly provided by Vasiliki Skandalou, Athens, Greece

Study Information for Patients

Informed Consent

kindly provided by Idit Matot and Anat Cattan, Tel-Aviv, Israel

Study Information for Patients + Informed Consent

kindly provided by Caterina Aurilio, Naples, Italy

Study protocol (version 2.4.2)

kindly provided by Fernando Abelha, Porto, Portugal

Study Information for Patients

Informed Consent

kindly provided by Jaume Canet, Badalona, Spain

Summary - Resumen

Study Information for Patients

Informed Consent

kindly provided by Mert Senturk, Istanbul, Turkey

Study Information for Patients + Informed Consent

Study protocol (version 2.4.2)

kindly provided by Gary Mills and Erica Wallis, Sheffield, England

15-wa-0106_favop_v2.pdf

esa-wg-provenet_letter_of_acceptance_26jun2014.pdf

iras_167739_probese_-_non_substantial_amendment.pdf

nhsrdform_snapshot.pdf

niaa_aagbi_grant_confirmation_letter_-_mills_g_20150721.pdf

probese_consultee_and_nominated_consultee_information_sheet_uk_version_v1.0._2015_jan_30.docx

probese_invitation_letter_v_1_may_2015.doc

probese_niaa_funding_confirmation_and_peer_review.pdf

probese_patient_information_sheet_uk_version_v1.1._2015_may_2015_clean_.docx

probese_sth18510_gp_letter_v1_2015jan30.docx

probese_study_checklist_for_consultee_telephone_opinion_v1_0_2015_jan_30.doc

probese_study_consent_form_v1.1_sept15.docx

probese_study_consultee_declaration_form_v1.0._2015_jan_30.doc

probese_study_nominated_consultee_declaration_form_v1.0._2015_jan_30.doc

probese_study_regaining_capacity_consent_form_v1.1_sept2015.docx

probese_study_protocol_v3_uk_may_2015_clean_.doc

Poster

Flyer

Screening log

CRF Guide (including eCRF)

SOP Plasma collection

SOP Urine collection

Estimation of Waist-to-Hip-Ratio according to WHO ( for summary: See paper version of CRF, definitions)

Convertion of O2 fresh gas flow to actual FiO2

Screening form with BMI table (e.g. for lamination)